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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMEN'S HEALTH MESH PRODUCT; UNKNOWN MESH
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMEN'S HEALTH MESH PRODUCT; UNKNOWN MESH Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Neurological Deficit/Dysfunction (1982); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
 
Event Description
It was reported that the patient alleged she experienced neurological problems after the mesh was implanted.The article did not identify the implant used to treat the patient.There was no manufacturer, brand, name or product identifiers.The request was prompted from a recent article published in the sunday post (aug 12th, 2018).Https://www.Sundaypost.Com/fp/memos-reveal-mesh-firms-were-warned-21-years-ago-that-material-should-not-be-used-on-humans/.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the women's health mesh product ifus are found to be adequate based on past reviews.Correction: outcomes attributed to adverse event.
 
Event Description
It was reported that the patient alleged she experienced neurological problems after the mesh was implanted.The article did not identify the implant used to treat the patient.There was no manufacturer, brand, name or product identifiers.The request was prompted from a recent article published in the sunday post (aug 12th, 2018).Https://www.Sundaypost.Com/fp/memos-reveal-mesh-firms-were-warned-21-years-ago-that-material-should-not-be-used-on-humans/.
 
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Brand Name
UNKNOWN BMD WOMEN'S HEALTH MESH PRODUCT
Type of Device
UNKNOWN MESH
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7895320
MDR Text Key120964489
Report Number1018233-2018-04330
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K093747
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/29/2018
Initial Date FDA Received09/20/2018
Supplement Dates Manufacturer Received11/16/2018
Supplement Dates FDA Received11/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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